BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL -ELUTING STENT

    MDR report key: 735842 · Received July 13, 2006

    Report

    Report Number
    6000093-2006-01280
    Event Type
    Death
    Date Received
    July 13, 2006
    Date of Event
    December 5, 2004
    Report Date
    June 19, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE NO ANALYSIS COULD BE PERFORMED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 6336993 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFOMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THT 202 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO LESION. THE TARGET LESION WAS IDENTIFIED IN THE SVG TO THE RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, MILD CALCIFICATION AND A 2.75MM REFERENCE VESSEL DIAMETER AND 7MM LENGTH. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 12MM TAXUS EXPRESS2 DRUG ELUTING STENT. THERE WAS NO RESIDUAL STENOSIS AND TIMI FLOW 3. POST - PROCEDURE, THE PATIENT HAD FOLLOW UP EVALUATIONS COMPLETED FOR HIS CONTRAST NEPHROPATHY, PULMONARY NODULES AND LIVER LESIONS (PATIENT DECLINED FURTHER WORK UP OR TREATMENT), URINARY TRACT INFECTION (TREATED WITH AUGMENTIN), ECCHYMOTIC GROIN (ULTRASOUND NEGATIVE FOR PSEUDOANEURYSM OR HEMATOMA), AND ATRIAL FIBRILLATION (MAINTAINED ON METOPROLOL - PATIENT DISCHARGED WITH SUPRATHERAPEUTIC INR). THE PATIENT WAS DISCHARGED 8 DAYS LATER ON PLAVIX AND ASPIRIN. THE STUDY SITE WAS UNABLE TO CONTACT THE PATIENT FOR THE 1 - OR 2-YEAR FOLLOW UPS. THERE WAS NO FORWARDING ADDRESS OR TELEPHONE NUMBER. A SEARCH OF THE SOCIAL SECURITY DEATH INDEX WEBSITE REVEALED THAT THE PATIENT HAD EXPIRED 202 DAYS AFTER THE INDEX PROCEDURE. NO ADDITONAL INFORMATION REGARDING THE DEATH IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL -ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP 25.75X12MM 6336993

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death